Malaysia: Requirements for Labelling of Medical Device Fifth Edition

ARQon
Sep 30, 2022
1 min read

In order for the user to get technical support, the fifth version of the MDA/GD/0026 places a strong emphasis on the necessity for a local manufacturer and AR contact information, such as an email, phone number, and website, in the labelling. As a result, Table 1 below compares the prior and present recommendations.

The MDA allows a transitional period until December 31, 2022 to let all establishments to comply with the labelling requirements established in this fifth edition of the MDA/GD/0026 guidance.

The "Requirements for Labelling of Medical Devices (MDA/GD/0026), Fifth Edition," will take effect on January 1, 2023, which specifies the labelling requirements that must be met by any businesses wanting to import and distribute medical devices into the Malaysian market.

Section	Title	Fourth Edition	Fifth Edition
4.1	Sample Format	No Sample format for the Malaysian Medical Device Registration Number label.	It is encouraged to use QR code to indicate medical device registration number available from medical device registration certificate. Examples of the format allowed: MDA Reg. No. xxxxxxx Registered with MDA GXXXXX Registration No. Gxxxxxxx Gxxxxxxx Malaysia Reg. No. XXXXXXX Medical Device Registration No. XXXXXXX MDA GXXXXX
4.5	Location of Labelling	Information in Bahasa Malaysia will be translated to English; or the location of the translation may be decided through a risk assessment exercise that shall be submitted during registration	For information that are provided on the label, Bahasa Malaysia translation shall be provided on the label itself.
4.8	General Contents	(a)   Details of medical device to enable user to identify it, which include name (brand and name of the device), identifier and model;	(a) Details of medical device to enable user to identify it, which include name (brand name, generic name, and specified name) of the device, model and identifier;
4.8	General Contents	(i) Any decommissioning or disposal information (infection or microbial hazards, environmental hazards; physical hazards)	(k) Any decommissioning or disposal information, if applicable and based on risk assessment (for example: infection or microbial hazards, environmental hazards; physical hazards).
4.8	General Contents	No clause of 4.8.2 and 4.8.3	Addition of: 4.8.2 The information in 4.8.1 f) g) h) i) and other necessary information may be provided, in the form of insert or other types of labelling, after applying risk management as according to ISO 14971. 4.8.3 For all labelling information, requirements on MDA/GD/0032, Code of Advertisement (COA) shall be observed.